Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

This study is ongoing, but not recruiting participants.

Sponsor:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT01004978

First Posted: October 30, 2009

Last Update Posted: September 26, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.

PFS [ Time Frame: Time from randomization to progression or death without evidence of progression, assessed up to 16 months ]

All PFS analyses will use the multi-time point (for the vascular invasion at 4, 8 and 12 months, and the non-vascular invasion group at 8, 12 and 16 months) Cochran-Mantel-Haenszel (CMH) test of Freidlin, et al. with an overall one-sided 0.025 type I error. The p-value from the one-sided multi-time point CMH test will be compared to the truncated O'Brien-Fleming boundary.

Secondary Outcome Measures:

Incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 4 years ]

Overall survival [ Time Frame: Time from randomization to death from any cause, or last known date of survival, assessed up to 4 years ]

Analyses will use a one-sided logrank test stratified on vascular invasion (yes vs. no) and Child-Pugh Score (A vs. B7), using a one-sided overall type I error of 0.025. Critical values at interim analyses will be determined using a truncated version of the Lan-Demets error spending rate function corresponding to the O'Brien-Fleming boundary.

ARM II: Patients receive placebo PO BID in the absence of disease progression or unacceptable toxicity. Beginning within 2 weeks after a stable dose of placebo is reached, patients undergo TACE as in Arm I.

MAINTENANCE THERAPY: After completion of chemoembolization, patients receive sorafenib tosylate or placebo as in Arm I and II in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 years.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below: